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Study to Evaluate the Effects of BMS-813160 on Protein Loss in the Urine of Subjects With Type 2 Diabetes and Diabetic Kidney Disease
A Double-Blind, Placebo-Controlled, Randomized, Two-stage, Parallel-Group, Adaptive Design Phase 2a Study to Evaluate the Effects of BMS-813160 in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (DKD) Who Have Residual Macroalbuminuria Despite Treatment With an Inhibitor of the Renin-Angiotensin System
2 other identifiers
interventional
319
4 countries
62
Brief Summary
The purpose of this study is to determine whether BMS-813160 will reduce the amount of protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2013
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2012
CompletedFirst Posted
Study publicly available on registry
December 19, 2012
CompletedStudy Start
First participant enrolled
March 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2015
CompletedResults Posted
Study results publicly available
June 25, 2019
CompletedJuly 30, 2019
July 1, 2019
2.3 years
December 17, 2012
March 21, 2019
July 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160
The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period.
Baseline, Weeks 2, 4, 8, 12, and 16 (Follow-up)
Secondary Outcomes (6)
Number of Participants With Serious Adverse Events (SAEs), Who Died and With Other (Not Including Serious) Adverse Events
From the date of subject's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
Number of Participants With Out-of-Range Electrocardiogram (ECG) Interval
Baseline up to Week 16
Trough Observed Plasma Concentration (Ctrough) of BMS-813160
Pre-dose at Week 2, 4, 8, 12 and 0.5, 1, 2, 4, and 6 hours post-dose at Week 12
Area Under The Plasma Concentration-Time Curve From Time Zero to 6 Hours Post-Dose [AUC(0-6 h)]
Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12
Renal Clearance (CLr) of BMS-813160
Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12
- +1 more secondary outcomes
Study Arms (3)
Arm A: BMS-813160 150 mg & Placebo matching with BMS-813160
EXPERIMENTALBMS-813160 150 mg capsules by mouth in AM and Placebo matching with BMS-813160 in PM for 12 weeks
Arm B: BMS-813160 300 mg
EXPERIMENTALBMS-813160 300 mg capsules by mouth twice daily for 12 weeks
Arm C: Placebo matching with BMS-813160
PLACEBO COMPARATORPlacebo matching with BMS-813160 0 mg capsules by mouth twice daily for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of type 2 diabetes mellitus with macroalbuminuria (UACR between 200 and 3500 mg/g)
- Background angiotensin converting enzyme inhibitor (ACEI) or angiotensin-receptor blocker (ARB) therapy
You may not qualify if:
- Clinical diagnosis of type 1 diabetes
- Unstable cardiovascular, metabolic, or other chronic disease status
- Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2
- High risk of infection or immune compromise
- Clinically significant ECG conduction abnormalities
- Drugs with significant potential to affect BMS-813160 exposure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Uab Hospital
Birmingham, Alabama, 35294, United States
Univ Of Al At Birmingham
Birmingham, Alabama, 35294, United States
Akdhc Medical Research Services Llc
Phoenix, Arizona, 85012, United States
Academic Medical Research Institute
Los Angeles, California, 90022, United States
Ucla
Los Angeles, California, 90025, United States
Providence Clinical Research
North Hollywood, California, 91606, United States
Diabetes Medical Center Of California
Northridge, California, 91325, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
All Medical Research, Llc
Cooper City, Florida, 33024, United States
International Research Associates, Llc
Hialeah, Florida, 33012, United States
Genesis Clinical Research, Inc.
Tampa, Florida, 33614, United States
Emory University School Of Medicine
Atlanta, Georgia, 30303, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076, United States
John H. Stroger, Jr. Hospital Of Cook County
Chicago, Illinois, 60612, United States
Research By Design, Llc
Evergreen Park, Illinois, 60805, United States
St Louis Center Clinl Res
St Louis, Missouri, 63128, United States
St. Louis Center For Clinical Research
St Louis, Missouri, 63128, United States
Va Nebraska-Western Iowa Health Care System (Nwihcs)
Omaha, Nebraska, 68105, United States
Southern Nh Diab And Endo
Nashua, New Hampshire, 03063, United States
Premier Research, Inc.
Trenton, New Jersey, 08611, United States
Albany Medical College
Albany, New York, 12206, United States
The Endocrine Group Llp
Albany, New York, 12206, United States
Nephrology Associates
Flushing, New York, 11355, United States
Medispect Medical Research, Llc
Boone, North Carolina, 28607, United States
Metrolina Internal Medicine
Charlotte, North Carolina, 28204, United States
Duke University
Durham, North Carolina, 27705, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Paramount Medical Research & Consulting, Llc
Middleburg Heights, Ohio, 44130, United States
Physician Research, Inc.
Zanesville, Ohio, 43701, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Piedmont Health Grp, Llc-Twr Pt Res Ctr
Hodges, South Carolina, 29653, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-1371, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Doctors Hospital At Renaissance
Edinburg, Texas, 78539, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234-6200, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234, United States
Northeast Clinical Research Of San Antonio, Llc
Schertz, Texas, 78154, United States
Burke Internal Medicine And Research
Burke, Virginia, 22015, United States
Virginia Endocrinology Research
Chesapeake, Virginia, 23321, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Mcguire Va Medical Center
Richmond, Virginia, 23249, United States
Health Sciences Centre Diabetes Research Centre
Winnipeg, Manitoba, R3A 1R9, Canada
Eastern Health Sciences Center
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Aggarwal And Associates
Brampton, Ontario, L6T 0G1, Canada
Clinical Research Solutions, Inc
Kitchener, Ontario, N2H 5Z8, Canada
Lmc Diabetes & Endocrinology (Thornhill)
Thornhill, Ontario, L4J 8L7, Canada
Lmc Diabetes & Endocrinology (Bayview)
Toronto, Ontario, M4G 3E8, Canada
Centre De Recherche Clinique De Laval
Laval, Quebec, H7T 2P5, Canada
Recherche Gcp Research
Montreal, Quebec, H2R 1V6, Canada
Local Institution
Montreal, Quebec, H3T 1E2, Canada
Local Institution
Frederiksberg, 2000, Denmark
Local Institution
Gentofte Municipality, 2820, Denmark
Local Institution
Hillerød, 3400, Denmark
Local Institution
Holstebro, 7500, Denmark
Local Institution
Amiens, 80054, France
Local Institution
Grenoble, F38043, France
Local Institution
Nantes, 44093, France
Local Institution
Paris, 75877, France
Local Institution
Poitiers, 86021, France
Local Institution
Tours, 37044, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2012
First Posted
December 19, 2012
Study Start
March 18, 2013
Primary Completion
June 30, 2015
Study Completion
June 30, 2015
Last Updated
July 30, 2019
Results First Posted
June 25, 2019
Record last verified: 2019-07